Acute Lymphoblastic LeukemiaINO-CD22NCT03898128
ItaliaN Observational Study of Patients With Acute Lymphoblastic Leukemia Treated With Anti-CD22 Immunoconjugate
An observational study of Acute Lymphoblastic Leukemia, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 5 sites in Italy.
Trial summary
In phase 2 and phase 3 studies, inotuzumab has shown evidence of single agent anti-leukemic activity and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2014 anti-CD22 has been available for compassionate use in Italy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Anti-CD22 Immunotoxin
- How many people
- 84 participants
- Where
- 5 sitesItaly
- Study dates
- 27 Nov 2019to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ALL patients treated with anti-CD22 immunoconjugate drugs from 1-Jan-2014 to 01-Mar-2019
Who may be able to join
- Patient with ALL according WHO 2016 classification.
- Patient who received any anti-CD22 immunoconjugate from 2014 to 01-Mar-2019 outside clinical trials.
Who cannot join
- 1. Patients who received anti-CD22 treatment within a clinical trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Irst Irccs
Meldola (FC), FC, 47014
ULSS 3 Serenissima
Mestre, Venezia, 30174
AUSL Romagna
Ravenna, RA, 48121
Ospedale S. Eugenio
Roma, 00144
Azienda ULSS2 Marca Trevigiana
Treviso, TV, 31100
About this study
In phase 2 and phase 3 studies, inotuzumab has shown evidence of single agent anti-leukemic activity and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2014 anti-CD22 has been available for compassionate use in Italy.
In this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with ALL, to improve the knowledge about anti-CD22 treatment in clinical practice. Collecting data of patients and analyzing a large unbiased patient-set of patients receiving anti-CD22 immunoconjugates could enlarge our knowledge on therapies engaging CD22
Read the detailed description
In phase 2 and phase 3 studies, inotuzumab has shown evidence of single agent anti-leukemic activity and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2014 anti-CD22 has been available for compassionate use in Italy.
In this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with ALL, to improve the knowledge about anti-CD22 treatment in clinical practice.
Despite recent advancements in the treatment of hematological malignancies, still a considerable number of cases cannot be cured and represent real societal challenges with a relevant social and economic impact. Indeed, treatments are becoming more expensive and the current state of the art does not allow a good prediction of the therapeutic outcome. In particular, several steps of the diagnostic and therapeutic paths should be improved, from early and advanced diagnosis, in order to avoid treatment delays or impairment, to prognostic assessment and monitoring of therapeutic response. The unsatisfactory response to conventional chemotherapy has led to the development of high-cost targeted therapies, whose administration and schedules has to be guided by defined molecular criteria. Beside the economic perspective, these novel drugs have relevant side effects that cannot be predicted before treatment starts.
The management of hematological malignancies is further complicated by the high level of disease heterogeneity in terms of pathogenetic and molecular mechanisms. A number of subtypes have been defined for each disease, based on cytogenetic and molecular profiles and relevant differences can be even observed within the same disease subtype, leading to different clinical outcomes and responses to treatment and to guide therapeutic decisions for patients affected by CD22 positive ALL.
Due to the observational nature of the study, for the patient there is no benefit expected. For this observational nature of the study, for the patient there is no risk about his health. Data will be treated according GCP/EU laws/Italian laws/local laws according the most restrictive between these laws.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Anti-CD22 Immunotoxin
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD22 ImmunotoxinDrug
Clinical data (treatment, survival, adverse events) of patients treated with anti-CD22 immunoconjugates from 2014 will be collected
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events of grade 3 and 4
toxicity profile of the therapy with antiCD22 immunoconjugates in patients with ALL
Measured: up to 12 months
Secondary outcomes (3)
Overall survival
Overall Survival (OS), defined as the number of days between the first study drug administration and death from any cause
Measured: up to 18 months
Disease free survival
Disease Free Survival (DFS), defined as the number of days between the first study drug administration and any event including disease progression or death from any cause
Measured: up to 18 months
Response to therapy
response to therapy (CR, CRi, MRD and bridge to transplant)
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start27 Nov 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Martinelli, Prof, Study director, IRST IRCCSDelia Cangini, MD, Principal investigator, IRST IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898128
- Sponsor's protocol ID
- IRST204.03
- Acronym
- INO-CD22
- Status last verified
- Dec 2025
- First submitted
- 29 Mar 2019
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ItaliaN Observational Study of Patients With Acute Lymphoblastic Leukemia Treated With Anti-CD22 Immunoconjugate
- ClinicalTrials.gov ID
- NCT03898128
- Acronym / sponsor ID
- INO-CD22 / IRST204.03
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In phase 2 and phase 3 studies, inotuzumab has shown evidence of single agent anti-leukemic activity and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2014 anti-CD22 has been available for compassionate use in Italy.
In this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with ALL, to improve the knowledge about anti-CD22 treatment in clinical practice. Collecting data of patients and analyzing a large unbiased patient-set of patients receiving anti-CD22 immunoconjugates could enlarge our knowledge on therapies engaging CD22
Detailed description
In phase 2 and phase 3 studies, inotuzumab has shown evidence of single agent anti-leukemic activity and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2014 anti-CD22 has been available for compassionate use in Italy.
In this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with ALL, to improve the knowledge about anti-CD22 treatment in clinical practice.
Despite recent advancements in the treatment of hematological malignancies, still a considerable number of cases cannot be cured and represent real societal challenges with a relevant social and economic impact. Indeed, treatments are becoming more expensive and the current state of the art does not allow a good prediction of the therapeutic outcome. In particular, several steps of the diagnostic and therapeutic paths should be improved, from early and advanced diagnosis, in order to avoid treatment delays or impairment, to prognostic assessment and monitoring of therapeutic response. The unsatisfactory response to conventional chemotherapy has led to the development of high-cost targeted therapies, whose administration and schedules has to be guided by defined molecular criteria. Beside the economic perspective, these novel drugs have relevant side effects that cannot be predicted before treatment starts.
The management of hematological malignancies is further complicated by the high level of disease heterogeneity in terms of pathogenetic and molecular mechanisms. A number of subtypes have been defined for each disease, based on cytogenetic and molecular profiles and relevant differences can be even observed within the same disease subtype, leading to different clinical outcomes and responses to treatment and to guide therapeutic decisions for patients affected by CD22 positive ALL.
Due to the observational nature of the study, for the patient there is no benefit expected. For this observational nature of the study, for the patient there is no risk about his health. Data will be treated according GCP/EU laws/Italian laws/local laws according the most restrictive between these laws.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALL patients treated with anti-CD22 immunoconjugate drugs from 1-Jan-2014 to 01-Mar-2019
Key inclusion criteria (2 listed)
- Patient with ALL according WHO 2016 classification.
- Patient who received any anti-CD22 immunoconjugate from 2014 to 01-Mar-2019 outside clinical trials.
Key exclusion criteria (1 listed)
- 1. Patients who received anti-CD22 treatment within a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-CD22 ImmunotoxinClinical data (treatment, survival, adverse events) of patients treated with anti-CD22 immunoconjugates from 2014 will be collected | Drug | – |
Primary outcome
Incidence of Adverse Events of grade 3 and 4
Time frame: up to 12 months
toxicity profile of the therapy with antiCD22 immunoconjugates in patients with ALL
3 secondary outcomes
Overall survival
Time frame: up to 18 months
Disease free survival
Time frame: up to 18 months
Response to therapy
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Martinelli, Prof study director
IRST IRCCS
Delia Cangini, MD principal investigator
IRST IRCCS
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events of grade 3 and 4 (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.